Kornimate/medical-research-clean huggingface dataset:
ambulatory blood pressure monitoring in the prediction of cardiovascular events and effects of chronotherapy

Conditions: Hypertension

Summary: the mapec study was designed to investigate whether normalizing the circadian blood pressure profile towards a more dipper pattern (increasing the diurnal/nocturnal ratio of blood pressure) by the use of chronotherapy (that is, taking into account the time of day of administration of antihypertensive medications) reduces cardiovascular risk.

target organ damage is more closely associated with ambulatory (abpm) than with clinic blood pressure (bp). in particular, the reduction of the normal 10 to 20% sleep-time bp decline (non-dipper pattern) is associated with elevated risk of end-organ injury, particularly to the heart, brain and kidney. these results suggest that cardiovascular risk could be influenced not by bp elevation alone, but also by the magnitude of the circadian bp variability. moreover, at least two independent prospective studies have suggested that nighttime bp is a better predictor of risk than daytime bp. common to all previous trials is that prognostic significance of abpm has relied on a single baseline profile from each participant, without accounting for possible changes in the bp pattern, mainly associated to antihypertensive therapy and aging during follow-up. the mapec study investigates, first, the comparative prognostic value of several bp parameters (including, among many others, bp variability, the diurnal/nocturnal ratio, diurnal and nocturnal means, slope of morning rise, etc) in the prediction of cardiovascular morbidity and mortality; and, second, whether potential changes in the circadian bp pattern after chronotherapy with antihypertensive drugs are associated to changes in cardiovascular risk.

Eligibility criteria:
inclusion criteria: * essential hypertension exclusion criteria: * aids * shift workers * secondary hypertension * intolerant to abpm

Keywords: ambulatory blood pressure monitoring cardiovascular risk chronotherapy circadian pattern
a study of patients with pure red cell aplasia associated with recombinant human erythropoietin treatment

Conditions: Pure Red-cell Aplasia

Summary: the purpose of this study is to investigate the relationship of anti-erythropoietin antibodies to the clinical course and outcome of pure red cell aplasia (prca) in participants currently or previously treated with recombinant human erythropoietin.

this is a multicenter (study conducted at multiple sites), observational (study in which the investigators/physicians observe the participant's data and measure their outcomes) study. approximately 150 participants will be enrolled in this study. the study consists of an initial observation phase and extended observation period. an initial observation phase starting at enrollment and ending when 24 months have elapsed since the date of loss of efficacy (loe), supplemented with retrospective data collection for the period between loe date and date of enrollment in the study. participants remaining epoetin alfa (epo-ab) positive 24 months after loe will enter a 2-year extended observation period. study visits will take place every month during the initial observation phase and data will be collected every 6 months during the extended observation phase. safety evaluations will include assessment of adverse events, clinical laboratory tests, vital signs, and physical examination which will be monitored throughout the study. the total study duration for each participant will be approximately for 4 years.

Eligibility criteria:
inclusion criteria: * pure red cell aplasia (prca) associated with recombinant human erythropoietin (r-huepo) treatment * anemia unresponsive to r-huepo treatment * prca associated with erythropoietin treatment followed by a sudden decrease (more than or equal to 2 gram per deciliter within 30 days) in a previously stable hemoglobin level exclusion criteria: - participants who are not fulfilling the inclusion criteria

Keywords: pure red-cell aplasia anemia red blood cells epoetin alfa (eprex) anti-erythropoietin antibodies recombinant human erythropoietin
an observational, multicenter study to evaluate the use and effectiveness of doptelet® in patients with itp

Conditions: Immune Thrombocytopenia; ITP

Summary: this is a multi-center, observational, phase 4 study in patients with immune thrombocytopenia (itp) designed to describe the real-world effectiveness of doptelet and assess the patterns of drug utilization to add to the knowledge base regarding the use of doptelet in routine medical practice. patients eligible for participation will, as part of their routine medical care, be receiving doptelet for the treatment of itp.

this is a multi-center, observational, phase 4 study in patients with itp designed to describe the real-world effectiveness of doptelet and assess the patterns of drug utilization to add to the knowledge base regarding the use of doptelet in routine medical practice. patients eligible for participation will, as part of their routine medical care, be receiving doptelet for the treatment of itp. the scope of the study is to collect both retrospective and prospective data. the main part of the study will be prospective collecting data on usage, effectiveness, safety, patient- and clinician-reported outcomes and health economic parameters whereas the retrospective part will consist of collection of information on previous treatments, reason for treatment switch, healthcare resource use and, if applicable, doptelet treatment prior to enrollment. the retrospective data collection will be based on the information available in the patient's medical records. data will be collected for up to 12 months prior to doptelet treatment start. prospective data will be collected at routine clinical visits throughout the study. patients will be followed for 12 (+6) months and will be enrolled until their first scheduled visit after 12 months of enrollment, or until early termination, whichever occurs first.

Eligibility criteria:
inclusion criteria: 1. patient is ≥18 years of age 2. established and well documented itp diagnosis 3. patient is treated with, or at enrollment prescribed, doptelet for itp. decision to initiate treatment shall be made by the treating physician and independently from the decision to include the patient in the study 4. signed and dated informed consent provided by the patient before any study-related activities are undertaken 5. willing and able to comply with protocol requirements exclusion criteria: 1. enrollment in a concurrent clinical interventional study, or intake of an investigational medicinal product (imp), within three months prior to inclusion in this study 2. itp secondary to evan's syndrome, lupus and other autoimmune diseases 3. itp secondary to other hematological disorders and hematological malignancies 4. itp secondary to any other malignancies 5. itp secondary to known drug toxicity 6. itp secondary to any other disease considered relevant by the investigator

Keywords: tpo ra (thrombopoietin receptor agonists )
study on the application of gratitude intervention in patients with spinal cord injury

Conditions: Patients ； Spinal Cord Injury

Summary: to analyze the present situation and influencing factors of gratitude level and quality of life of patients with spinal cord injury, and to explore the methods of thanksgiving intervention for patients with spinal cord injury so as to provide scientific basis for improving the quality of life of patients with spinal cord injury. investigation and research design and experimental research design

effectiveness evaluation indicators: (1) main efficacy indicators: gratitude level scale (c-gq-6) score, quality of life scale (whoqol-bref) score; (2) secondary efficacy index: positive psychological capital scale (ppq) score; trait coping style (tcsq) score, perceived social support scale (psss) score. inclusion criteria: accorded with the 6th edition of neurological classification of spinal cord injury issued by the american spinal cord injury society, and confirmed by ct or mri imaging; sequelae such as limb motor dysfunction caused by spinal cord injury; age ≥ 18 years old; returned to the community after discharge from hospital for at least 2 weeks; good language communication skills, volunteered to participate in this study; exclusion criteria: spinal cord injury caused by non-trauma (such as bone tumor, spinal cord angiopathy, medical operation, etc.); patients with brain organic diseases; those who were diagnosed with mental disorders; unwilling to participate in this researcher;

Eligibility criteria:
inclusion criteria: * conformed to the 6th edition of neurological classification of spinal cord injury issued by the american spinal cord injury society, and confirmed by ct or mri imaging; sequelae such as different degrees of limb motor dysfunction caused by spinal cord injury; age ≥ 18 years old; returned to the community after discharge from the hospital for at least 2 weeks; good language communication skills, volunteered to participate in this study; exclusion criteria: * non-traumatic spinal cord injury (such as bone tumor, spinal cord angiopathy, medical operation, etc.); patients with brain organic diseases; those with definite diagnosis of mental disorders; unwilling to participate in this researcher;
biological sex and cteph-related rv dysfunction and recovery (biosphere)

Conditions: CTEPH

Summary: 1. to identify biological sex differences in baseline rv function in cteph 2. to identify biological sex differences in recovery of rv function after pte surgery in cteph 3. to determine if sex hormone levels relate to rv function at cteph diagnosis and during recovery after pte.

aims 1 and 2 together comprise a retrospective cohort study. we will identify historical subjects with newly diagnosed cteph using a clinical database. we will perform tte strain analysis (rvgls) to compare rv function between the biologic sexes at diagnosis and after surgical correction of cteph (to assess recovery).

Eligibility criteria:
inclusion criteria * adult (≥18 years old) patients diagnosed with cteph per current guideline standard42 * subject must have a baseline tte (within 3 months of diagnosis) with adequate images for rvgls analysis * subject must have a right heart catheterization (rhc) at the time of diagnosis * to be included in the aim 2 analysis, patients must undergo pte surgery and have a tte performed 3-9 months after surgery with adequate images for rvgls strain analysis exclusion criteria * unclear or mixed ph diagnosis as designated by an expert clinician at intermountain ph center * any subjects \<18 years of age * patients diagnosed during pregnancy * patients without a tte and rhc at time of diagnosis
cardiovascular registry of atrial fibrillation

Conditions: Atrial Fibrillation; Atrial Flutter

Summary: follow a representative sample of latin american patients diagnosed with atrial fibrillation to set data on demographic characteristics, documenting antithrombotic therapy, describe the inr control level of vka users, discontinuation rates and clinical outcomes, such as stroke, hemorrhage and death

patients will be followed 6 months and 1 year after the baseline visit and will be collected data of antithrombotic therapy, laboratory data, discontinuation rates of antithrombotic therapy and clinical outcomes.

Eligibility criteria:
inclusion criteria: * age \> 18 years-old that signed informed consent; * atrial fibrillation or atrial flutter at the time of inclusion documented in source document; * if the patient is not in atrial fibrillation or atrial flutter rhythm, s/he should have 2 electrographic records, at least 15 days apart between them, with one of them being performed within the last 6 months before enrollment (af may be documented by 12-lead ecg, holter monitor-24h); exclusion criteria: * patients who did not agree to participate. * patients without possibility of monitoring for one year.

Keywords: atrial fibrilation antithrombotic therapy atrial flutter
thoracoscopic lung cancer staging with the use of intraoperative ultrasound

Conditions: Lung Cancer

Summary: all patients undergoing video-assisted thoracoscopic (vats) resection of lung cancer will receive standard therapy including lobectomy or sub-lobar resection and mediastinal lymph node dissection. after completion of the standard of care, intraoperative ultrasound will be used to evaluate lymph node stations for the presence of any missed lymph nodes with particular focus on lymph nodes which may appear pathologic on ultrasound evaluation. data will be reviewed for rates of pathologic upstaging, and sensitivity and specificity of ultrasound as an additional diagnostic tool in the operating room will be evaluated. it is hypothesized that intra-operative thoracoscopic ultrasound following standard video-assisted thoracoscopic (vats) dissection will increase the rate of pathologically staged in n2 nodes in non-small cell lung cancer patients undergoing definitive surgical resection.


Eligibility criteria:
inclusion criteria: age ≥18 years. eastern cooperative oncology group performance status ≤2 (karnofsky ≥60%, see appendix a). life expectancy of greater than 3 months patients be able to undergo vats resection as defined below: * preoperative forced expiratory volume at one second ≥ 40% predicted * or * post-operative predicted forced expiratory volume at one second ≥ 0.8 l * hg ≥ 8.0 * no evidence of coronary ischemia on stress evaluation ability to understand and the willingness to sign a written informed consent document. exclusion criteria: patients with surgery for a prior ipsilateral lung cancer patients with known brain metastases uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. (patients with hiv are not excluded from this study)

Keywords: lung cancer ultrasound staging
efficacy and safety of lubiprostone in patients with irritable bowel syndrome with constipation

Conditions: Irritable Bowel Syndrome; Constipation

Summary: the primary purpose of this study is to evaluate the efficacy and safety of administration of lubiprostone in patients with irritable bowel syndrome with constipation.


Eligibility criteria:
inclusion criteria: * 18 years of age and older * stable fiber therapy * normal colonoscopy/sigmoidoscopy * able to refrain from use of medications known to treat or associated with constipation symptoms * experiences abdominal discomfort/pain associated with bowel movements * reports decreased bowel movement frequency and/or other symptoms associated with constipation exclusion criteria: * diarrhea-predominant or alternating (diarrhea \& constipation cycling) ibs, or constipation other than that associated with ibs * open gastrointestinal or abdominal surgery prior to ibs onset * organic bowel disorder, mechanical bowel obstruction, pseudo-obstruction, unexplained weight loss or rectal bleeding * uncontrolled cardiovascular, liver or lung disease, neurologic or psychiatric disorder, other systemic disease, or abnormal laboratory tests per investigator discretion * if female, is currently pregnant or nursing, or plans to become pregnant or nurse during the clinical study

Keywords: irritable bowel syndrome with constipation
punicalagin and hydroxytyrosol mixture on different inflammatory markers

Conditions: Healthy

Summary: a crossover trial was carried out in healthy volunteers aged 45-70 years and bmi \<30 kg/m2. subjects consumed a antioxidant supplement (as) containing 65 mg of punicalagin mixed with 3.3 mg of hydroxytyrosol 3 times daily or a control supplement (cs) with maltodextrin for an 8 wk each phase with 4-wk rest period. supplementation order was randomly assigned and the consumption of derivative products of punicalagin and/or hydroxytyrosol restricted. the endothelial function parameters (brachial artery flow-mediated dilation (fmd), biochemical markers), inflammatory markers and nutritional status were evaluated before and after each phase. previously a pilot study was completed with no placebo (n=30) to determinate the effective dose of functional supplement.


Eligibility criteria:
inclusion criteria: * men and women from 45 to 75 years old; * signed informed consent exclusion criteria: * individuals with cardiovascular risk factors on drug treatment (dyslipidemia, hypertension, diabetes mellitus); * individuals with metabolic syndrome; * individuals with familiar background of premature cardiovascular disease; * individuals with bmi ≥ 30 kg/m2; * women that still maintain your menstrual cycle; * individuals with increased alcohol consumption 30g/day; * individuals that stop smoking in the next 20 weeks (during the study); * individuals that consume antioxidant supplement, drugs, ω-3 supplements, vitamins, minerals, prebiotics or/and probiotics; * women that consume oral contraceptive; * individuals with mental disease or low cognitive function; * individuals with severe diseases (hepatic, kidney, cancer...); * individuals with drugs or supplements consumption to weight lost; * pregnant women or lactating; * individuals with intensive physical activity; * individuals with physical problems complying with the recommendations of physical activity and diet general recommendations.

Keywords: cross-over studies antioxidants hydroxytyrosol punicalagin treatment outcome inflammatory markers endothelial function humans adults volunteers
evaluating the outcomes for incisional application of negative pressure for nontraumatic amputations

Conditions: Surgical Wound; Wound Heal; Amputation

Summary: the purpose of this study is to evaluate how well subjects heal after surgery who receive standard dressings or incisional negative pressure wound therapy for non-traumatic amputation sites.

incisional negative pressure wound therapy is an approved device used for wound healing of closed surgical incisions. this research is being done because incisional negative pressure wound therapy is a new application of negative pressure wound therapy that is applied over a closed incision area instead of an open wound. negative pressure wound therapy is commonly used to help heal open wounds. it involves the use of a piece of foam, an adhesive drape, and a battery-powered device that places negative pressure on the wound. currently, there are no trials utilizing incisional negative pressure wound therapy of closed wounds after below knee amputations (bka), transmetatarsal amputations (tma), knee disarticulations (kd), and above knee amputations (aka). this is a pilot study that compares incisional negative pressure wound therapy and standard dressings in patients.

Eligibility criteria:
inclusion criteria: 1. must be at least 18 years or older to participate. 2. requires closure of a nontrauamtic transmetatarsal amputation (tma), below knee amputation (bka), knee disarticulation (kd), or above knee amputation (aka). 3. has at least one artery that feeds the closure site. 4. able to comply with clinical trial procedures and schedule. exclusion criteria: 1. patients not receiving an amputation. 2. the investigator/provider determines that the patient has an indication against incisional negative pressure wound therapy that would prevent them from participating. 3. surgical incision that is not completely closed.
comparison of efficacy and safety of narrowband uvb with 0.1% tacrolimus vs narrowband uvb with 0.005% calcipotriol in treatment of vitiligo

Conditions: Vitiligo - Macular Depigmentation; Tacrolimus

Summary: patient of stable and limited vitiligo less than 20% bsa will be recruited and evaluation of efficacy and safety of narrowband uvb with topical tacrolimus vs narrowband uvb and calcipotriol will be assessed

evaulation of efficacy and safety of narrowband uvb and tacrolimus and nbuvb and calcipotriol in patient if stable vitiligo with body surface area less than 20% it will be assessed by vasi score and viisual analogie scale

Eligibility criteria:
inclusion criteria: - localized vitiligo age 15 to 70years body surface upto 20% stable more than 3 months exclusion criteria: * • pregnant or lactating female patients. * skin malignancy or any other malignant skin condition. * photo induced or photo aggravated dermatosis like (sle, photodermatitis, rosacea, psoriasis, pemphigus vulgaris) along with vitiligo. * prior history of allergy to tacrolimus or calcipotriol. * other form of treatment for vitiligo within at least 1 month.

Keywords: vitiligo
planning for success

Conditions: HIV

Summary: planning for success (sustained, unbroken connections to care, entry services, and suppression) is a project to improve the connection to community care for hiv infected persons leaving fulton county jail or atlanta city detention center in atlanta. hypothesis: participants who receive the intervention will be more likely to link to medical care after jail release than similar participants who do not receive the intervention. rationale and objective: this project aims to make sure hiv positive persons leaving jail maintain medical care. case managers will use strength based case management and phone texting technology to improve release's connections to care in the community. this study will have extensive tracking of outcomes. the key outcome will be whether hiv infected participants receiving an intervention experience suppression of their viral load after release from jail . the investigators wish to demonstrate the ability to recruit participants into the success intervention and repeatedly check community medical records to see how well their infection is being controlled after they linked to care. investigators also want to conduct a survey at baseline, 3 months and 12 months. investigators will compare the viral load of participants receiving the intervention to participants passing through the jail who do not receive the outcome.


Eligibility criteria:
inclusion criteria: * hiv infected (hiv+); age of or over 18 years; * mentally able to give consent; understand spoken english; * detained or sentenced in either the fulton county jail or the atlanta city detention center; and * likely to leave within 6 weeks exclusion criteria: * unable to give consent because of mental illness or inebriation; * a recent participant in a randomized trial conducted by the investigators of an intervention to increase retention in hiv care (e.g., artas)

Keywords: hiv jail detainee linkage and retention treatment as prevention strength based case management releases
evaluate the efficacy and safety of pasireotide lar (long acting release) on the treatment of patients with clinically non-functioning pituitary adenoma.

Conditions: Non-functioning Pituitary Adenoma

Summary: this study assessed pasireotide lar efficacy on patients with non-functioning pituitary adenomas concerning tumor growth.


Eligibility criteria:
inclusion criteria: * non-functioning pituitary adenoma ≥ 1cm, patients without any previous treatment for the tumor * eastern cooperative oncology group (ecog) performance status 0 or 1 exclusion criteria: * patients who required a surgical intervention for relief of any sign or symptom associated with tumor compression * previous pituitary surgery * previous medical treatment for pituitary tumor * patients who had received pituitary irradiation within 10 years prior to randomization * prolactin (prl) levels \> 100 ng/ml. prl evaluation should have been performed with diluted samples to ensure "hook effect." was avoided * patients who presented prolactinomas, acromegaly or cushing's disease * patients with compression of the optic chiasm causing acute clinically significant visual field defects

Keywords: non-functioning pituitary adenoma, pasireotide lar, tumor volume